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EC admits parallel trade a 'considerable risk'

Parallel trade is a hazardous and feebly regulated practice which requires 'political' solutions and possibly changes in European law, the vice president of the European Commission, Gunter Verheugen, has acknowledged, speaking in the European Parliament in January.

Parallel trade is a hazardous and feebly regulated practice which requires "political" solutions and possibly changes in European law, the vice president of the European Commission (EC), Günter Verheugen, has acknowledged, speaking in the European Parliament in January. 

The risks and iniquities to Europe's patients and markets of counterfeit medicines entering the supply chain through pharmaceutical parallel trade routes have been cited openly by the EC as a chief concern. "I would like to stress that I will prioritise the issue of parallel trade with fake pharmaceuticals. I have changed the work program of the DG and we will launch a legislative initiative," Verheugen announced. 

In part, Verheugen's comments represented the EC's reaction to a report, submitted to European Parliament in November 2007 by the European Alliance for Access to Safe Medicines (EAASM), on the weaknesses PT brings to the regulatory system, and the threats it permits to patients. Many of the report's conclusions were in line with EC's own findings, elicited from an analysis of the alleged threats and risks brought by the practice of European pharmaceutical parallel trade.

"Unfortunately, the first results of the study show that parallel trade brings a considerable risk for the safety of patients,' he said. "The reasons for that are numerous - eg, there are problems with the packaging and labelling of the products as well as with product recalls, the complexity of distribution channels and the supply."

He added: "Finally, it is difficult to effectively enforce the law."

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In an exclusive interview conducted at the European Parliament in November, Pharmaceutical Marketing Europe spoke to MEP Bill Newton Dunn, who admitted some surprise at the severity of the risks brought to Europe's patients through counterfeit medicines. 

"Existing laws are certainly not enough. We need a new way of fighting. Also needed is better cross-border enforcement against the criminal gangs - which means, as far as I can see, creating an 'FBI for Europe'."

Given its keen focus on developing effective public health policies, the EC has moved to elevate the priority of counterfeits and parallel trade.

Verheugen confirmed that the EC is developing a "coherent strategy to avoid these risks", and is currently examining several "political options" aiming to smooth out and stabilise price and supply issues across Europe. These could include a revision of the transparency directive to include specific information on pricing, as well as changes in the law to protect patients, which would require co-operation at Member State level.

The European parallel trade association (EAEPC) has reacted strongly to defend its practices, referring to the EAASM report as "black propaganda". Secretary-General Heinz Kobelt said of the report: "This is not about supply chain security but about attacking legitimate competition."

For a full report on the debate, see http://www.pmlive.com/index.cfm?showArticle=1&ArticleID=6330

22nd January 2008

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